The FDA’s Vape Fiasco Will Perpetuate Smoking Deaths

    What’s not to love to hate about the Food and Drug Administration’s non-decisions on nicotine vapes? We’re now almost two months past the FDA’s deadline to determine, through its Premarket Tobacco Product Applications (PMTA) process, whether different vaping products are “appropriate for the protection of public health.” To date, the agency has authorized exactly one vaping product out of countless submitted: R. J. Reynolds Vapor Company’s Vuse Solo—an outdated, tobacco-flavored cigalike device that almost no one uses.

    After years of an unrelenting teen-vaping panic, a flavor-ban frenzy, an insidious, ever-mutating disinformation campaign from tobacco harm reduction haters and the opening of a new front in the War on Drugs that targets any nicotine use, it’s no surprise.

    It’s also lame as fuck.

    The single positive—one in the eye for disgraced researcher Stanton Glantz, billionaire Michael Bloomberg, his proxies at Campaign for Tobacco-Free Kids (CTFK) and Parents Against Vaping E-Cigarettesis that the FDA finally had to admit that an e-cigarette is “Appropriate for the protection of public health … The toxicological assessment found the authorized products’ aerosols are significantly less toxic than combusted cigarettes.”

    But we knew this years ago—even before Public Health England’s seminal 2015 finding that vapes are around 95 percent less harmful than cigarettes. Almost half a million people, without adequate harm reduction or information, have continued to die annually of smoking-related causes in the United States ever since.

    But even this most basic acknowledgment was quickly qualified to mollify the champions of nicotine-free teen brains.

    If the FDA hadn’t made this admission, decision-makers at its Center for Tobacco Products (CTP) risked losing all credibility as irrelevant Flat Earthers. Hundreds of studies on vaping safety and efficacyevaluated by the Royal College of Physicians, the Cochrane Review, the National Academies of Sciences, Engineering, and Medicine—plus a recent paper that supports tobacco harm reduction authored by 15 former presidents of the Society for Research into Nicotine and Tobacco were simply impossible to dismiss.

    But even this most basic acknowledgment was quickly qualified to mollify the champions of nicotine-free teen brains.

    The tweet is yet more infuriating cognitive dissonance, and shows that nothing has fundamentally changed at the FDA. How many times does it have to be stated that vapes are not tobacco products: They contain zero tobacco! To assert that vapes are not safe, adding that they are “harmful and addictive,” creates fear and uncertainty for people who are currently inhaling the smoke that will end up killing half of them. The only metric that counts for these substitution products is the demonstrated, massive reduction in harm compared with cigarettes.

    And how can Vuse Solo be on the one hand “appropriate for the protection of public health” and on the other, “not safe” or “FDA approved?” To compound the confusion, the authorization doesn’t allow Reynolds to claim what’s true: that vaping is safer than smoking.

    The FDA’s negative, false and contradictory messaging is a set-up for failure. Why would millions of smokers even buy the Vuse Solo if the FDA says it’s not safe? And if smokers do try the outdated cigalike, many will find it unsatisfying and give up on switching. It’s a self-fulfilling prophecy. And anti-vaping groups will take advantage of this to make yet more specious arguments that vaping doesn’t help smokers quit.

    The CTP was never going to get the regulation of vaping products right because it framed the whole question in the wrong way—insisting that an e-cigarette show “enough of a benefit to adult smokers that would overcome the risk posed to youth.”

    It is striking how rarely in debates around vaping the FDA even mentions the people who die of smoking-related diseases.

    The CTP is obsessed with youth vaping rates and flavors. The two drive its every decision. The FDA press release on Vuse references the 2021 National Youth Tobacco Survey and states, “The agency takes these data very seriously and considered risks to youth when reviewing these products … The data also suggest that most youth and young adults who use [vapes] begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth…”

    Never mind that most adults whose lives can be saved by switching also prefer flavors. Never mind that most of the tiny fraction of youths who vape daily have previously smoked—nor that research suggests that without access to vapes, more teens would be smoking. Add to that the fact that teen vaping has declined steeply in the last two years.

    It is striking how rarely in debates around vaping the FDA even mentions the people who die of smoking-related diseases. It’s as if all those lives just disappeared and don’t matter. Media coverage reinforces the FDA’s adult-smoker blindspot. Coverage of the topic presents it as a business story or a political drama, with hot takes on “Big Vape,” Big Tobacco and of course, panic about The Children.

    To satisfy the anti-flavor lobby, the FDA rejected 10 of Vuse’s flavored e-liquid pods and is still reviewing its application for a menthol flavor. The agency warned, “Should any of them already be on the market, they must be removed or risk enforcement.” And to show who is really the big boss, Mitch Zeller, the CTP director, issued a threat that if the availability of Vuse Solo leads to “significant use” by youth, it will be taken off the market. Anti-vaping groups, which contend that any nicotine use in young people is dangerous, will make plenty of use of Zeller’s vague term.

    Predictably, groups that hate vaping are complaining about the authorization of Vuse Solo. The Truth Initiative and the American Lung Association  believe the e-cigarette contains too much nicotine. A Truth Initiative article stated, “Disappointingly, FDA’s decision on Vuse Solo keeps a high-nicotine product on the market and does nothing to address the issue of high nicotine content or nicotine delivery … The FDA must limit nicotine in e-cigarettes by capping nicotine strength and delivery as is done in other countries.”

    Wrong. Heavy smokers need sufficient levels of nicotine to avoid withdrawal and to successfully switch. That’s why e-liquids and pods come in different strengths. The ability to customize the amount of nicotine is one of the most important and innovative features of vaping products.

     

    A Rigged Process

    The PMTA process, created by those geniuses at the FDA, will go down in history as the most unfathomable  and asinine way to assess and authorize products that have been on the market for years and have already saved countless lives. The illogical and über-expensive PMTA pathway, with its requirement to submit reams of scientific documents, was a stark indication that the CTP doesn’t understand the unique landscape of the US vaping market.

    From the outset, the PMTA process was rigged to fail and bankrupt mom-and-pop vaping businesses and reward the liquidity of the tobacco industry. And sure enough, millions of PMTAs from small and medium businesses have been rejected. It’s curious, given that the CTP is in lockstep with organizations whose raison d’ être is putting Big Tobacco out of business, that it set up a system guaranteeing the corporate capture of the legal vaping market.

    For thousands of small and mid-sized business owners who manufacture, distribute and sell vape products, the PMTA pathway is the road to ruin.

    In addition, it’s hard to believe that CTP staff, with chronic understaffing and a process taking place during the COVID-19 pandemic, seriously evaluated millions of PMTAsand in fact, they didn’t. Despite the FDA’s protestations that each product was evaluated individually, at least dozens of companies received marketing denial orders (MDOs) in letters that were essentially identical.

    For thousands of small and mid-sized business owners who manufacture, distribute and sell vape products, the PMTA pathway is the road to ruin. MDOs effectively put them out of business.

    It is criminal to destroy this nationwide, community-based group of e-liquid manufacturers and vape stores that have helped hundreds of thousands of smokers make the switch. Many vape shop owners are former smokers who couldn’t quit until they tried vaping. To help other smokers, they created, from the ground up, a vaping ecosystem where none had existed. Product safety and efficacy and preventing sales to minors are central to their mission. And the FDA is shutting them down for what reason?

    Vape companies aren’t giving up the fight, though, and at least 28 have filed lawsuits against the FDA. Amanda Wheeler, the president of the American Vapor Manufacturers Association, is turning her anger into action against the CTP. “We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts,” she said. “We are not surrendering our business or abandoning vapers to cigarettes. As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”

    The FDA fiasco is a wake-up call that an entirely new vape product approval process needs to be created that is transparent, works collaboratively with all stakeholders, recognizes the immense contribution of the vaping community, and moves fast to get safer nicotine products to smokers.

     

    Mission Implausible

    The mission of the CTP—established by the 2009 Family Smoking Prevention and Tobacco Control Act—is “to make tobacco-related death and disease part of America’s past, not America’s future…” Nearly 40 million adults continue to smoke. Mission not accomplished, and the future isn’t looking good.

    The CTP has been so wrong for so long. In its utter dysfunction, it doesn’t recognize that a laser focus on teen use of e-cigarettes prevents investing resources in vulnerable populations who have the highest rates of smoking and morbidity and mortality. Focus on them—not on a shrinking group of wealthy, white teens experimenting with mango-infused nicotine in high school bathrooms to be rebellious and cool. The “kids” will be alright, and the vast majority will mature out of use.

    Compounding the problem is that the CTP has enlisted in the “forever war” against nicotine being waged by the Campaign for Tobacco-Free Kids, the Truth Initiative and PAVE. They will always use the tobacco industry’s past to destroy the future of the vaping industry.

    Kathleen Crosby, the director of the CTP’s Office of Health Communication and Education, developed the public education campaign against vaping called “The Real Cost.” The videos are an attempt to terrorize teens, replete with menacing worms invading their brains and bodies. Each 30-second spot contains exaggerations and lies of omission. They are a new iteration of the discredited Partnership for a Drug-Free America campaign: “This is your brain on drugs.” 

     

    Move Fast and Create Things

    The COVID-19 pandemic has forced society to rethink how it does everything. For 20 years the number of smokers worldwide has remained the same: 1.1 billion. Clearly, current tobacco control strategies don’t work. Now is the time to reenvision a set of policies that center people who smoke and vape.

    To that end, the CTP needs to be shut down. In its place, we should build a Center for Safer Nicotine Products, based on the principles of harm reduction, the right to health, and social and racial justice.

    Today, the harms of smoking in the United States and elsewhere are concentrated among the most oppressed groups: African Americans, Latinx and Indigenous populations who die disproportionately from smoking-related illnesses; the LGBTQ community; people who use illicit drugs; homeless people; and people with mental health diagnoses. Smokers are overwhelmingly poorer and less educated than the general population.

    The Center for Safer Nicotine Products would focus efforts on reducing smoking rates in the following groups:

     

     

    The needs of these groups for safer nicotine products should inform everything. If this country is serious about saving smokers’ lives, this is what must be done. Because a half million needless deaths a year is unacceptable as fuck.

     


     

    Photograph by Helen Redmond

    Reynolds American, Inc. has provided unrestricted grants to The Influence Foundation, which operates Filter. Filter‘s Editorial Indpendence Policy applies.

    • Helen is the senior editor of Filter. She has written about nicotine, mental health and drug policy for publications including Al Jazeera, AlterNet, Harper’s and The Influence. As an LCSW, she works with drug users in medical and community mental health settings. An expert on tobacco harm reduction, she provides training and consultation on mental health, nicotine use and THR, and in 2016 organized the first Tobacco Harm Reduction Conference in the US. Helen is also a documentary filmmaker.

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